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Safety Signal in Phase 2 Deals a Setback to BioAge Labs’ Muscle-Preserving Obesity Drug

MedCity News

BioAge Labs said the potential safety problem was observed in some who received experimental drug azelaprag, which is being tested as a monotherapy and in combination with Eli Lilly obesity medication Zepbound. No safety signals were observed in those who received Zepbound alone.

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Safety Risk Sinks Cargo Therapeutics’ Cancer Cell Therapy Prospect, Leading to 50% Staff Cut

MedCity News

The post Safety Risk Sinks Cargo Therapeutics Cancer Cell Therapy Prospect, Leading to 50% Staff Cut appeared first on MedCity News. Phase 2 data for Cargo Therapeutics CD22-targeting cell therapy show low durability and cases of a severe immune response, some that were classified as grade 4 or 5 serious adverse events.

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Safety Stands Out in Arcellx Cell Therapy’s ASH Data, But Don’t Overlook Manufacturing Advantages

MedCity News

The post Safety Stands Out in Arcellx Cell Therapys ASH Data, But Dont Overlook Manufacturing Advantages appeared first on MedCity News. Arcellx is developing its CAR T-treatment under a partnership with Gilead Sciences.

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Pfizer Stops Work on Oral GLP-1 Obesity Drug After Safety Signal Surfaces in Clinical Trial

MedCity News

Pfizer is stopping further work on this program, a move that comes nearly two years after it discontinued development of a different obesity drug due to liver safety signals in a clinical trial. The post Pfizer Stops Work on Oral GLP-1 Obesity Drug After Safety Signal Surfaces in Clinical Trial appeared first on MedCity News.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Revvity Signals provides a centralized analytics platform built to support today’s clinical study requirements and increase trial efficiency, glean actionable analytic insights, automate data collection and harmonization, support safety and efficacy decision-making, and enable a singular view across a company’s entire candidate portfolio.

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FDA Pushes Out Decision for Cytokinetics Heart Drug to Review Proposed Safety Plan

MedCity News

The post FDA Pushes Out Decision for Cytokinetics Heart Drug to Review Proposed Safety Plan appeared first on MedCity News. Analysts say this development could signal a change in FDA thinking about risk management for the broader drug class.

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Kansas AG accuses Pfizer of misrepresenting COVID vaccine, hiding safety risks in lawsuit

Fierce Pharma

Kansas Attorney General is accusing Pfizer of "misrepresenting" its vaccine's safety and efficacy in a 179-page civil suit.

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How Machine Learning Drives Clinical Trial Efficiency

Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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Commercial Drug Sourcing for Clinical Trials

Sponsors can face a number of challenges when trying to obtain these critical supplies for their studies, including addressing product lead times, availability, expiry limitations, safety and cost, among others.